Infinity Gateway Suite
FDA 510(k) clearance K233834 · decided 2024-07-12
Clearance details
- K-number
- K233834
- Device name
- Infinity Gateway Suite
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-04
- Decision date
- 2024-07-12
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.